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Sculptra: the New Three-Dimensional Filler
Abstract
Sculptra, the synthetic injectable poly-l-lactic acid (PLLA), is a revolutionary three-dimensional filler lasting 18 to 24 months. This unique volumizing agent is best used to globally restore volume to the lower two thirds of the face in patients who have lipoatrophy. Sculptra is a biocompatible, biodegradable, and nonimmunogenic derivative of the alpha-hydroxy-acid family. The size and the slow degradation kinetics of PLLA microparticles act as a stimulus for collagen production, providing lasting volume enhancement in lipoatrophy patients.
... The polymer PLLA is a resorbable biocompatible powder that is reconstituted with distilled water and lidocaine and used to add volume or as a biostimulator (concentration, 12-20 mL). 8 Calcium hydroxyapatite is a white material with microspheres (45 mm) of calcium hydroxyapatite in a carboxymethyl cellulose gel that may function as a filler, biostimulator, and inducer of new collagen formation within 6 months after injection. ...
... It anastomoses with the angular artery, the contralateral dorsal nasal artery, and the lateral nasal branch of the facial artery. (8) The facial artery arises from the external carotid artery and supplies structures of the face. The facial artery passes forward and upward across the cheek to the angle of the mouth, where it branches and gives rise to the labial systems and lateral nasal artery that supplies the ala and dorsum of the nose. ...
... The facial artery also anastomoses with the contralateral facial artery, septal and alar branches, dorsal nasal branch of the ophthalmic artery, and infraorbital branch of the internal maxillary artery. The facial artery ascends along the side of the nose, ending at the medial canthus, where it is named the angular artery (8,9,10). After supplying the lacrimal sac and orbicularis oculi, it ends by anastomosing with the dorsal nasal branch (11) of the ophthalmic artery. ...
Filler injection for cosmetic treatment of the aging face may be complicated by visual impairment, skin necrosis, or anaphylaxis because of accidental intravascular injection. Blood aspiration test (withdrawal of blood by the syringe plunger before injection) may decrease the risk of intravascular injection.
To evaluate the reliability of the aspiration test.
A red ink solution was withdrawn from a cup using a syringe containing 0.1 mL filler (17 different filler products); when there was no aspiration, retesting was performed with larger-gauge needles until aspiration was observed. In a white rabbit, aspiration was attempted after puncturing the ear vein and withdrawing the syringe plunger (5 different filler products).
The aspiration test with an ink solution in vitro was negative with 8 filler products (47%) and positive with 9 filler products (53%); for all products that had a negative aspiration test, the test became positive when a larger-gauge needle was used. All 5 products tested with the rabbit ear aspiration test were positive.
The aspiration test was reliable with 53% syringes and needles tested. Fillers that have a negative aspiration test may be applied when the needle gauge is adjusted.
... Off-label cosmetic use is common. The longevity of PLLA (18 to 24 months) is because of the slow degradation kinetics of the large, irregularly shaped PLLA microparticles, which measure 40 to 63 μm and have a high molecular weight of 140,000 Da. 15 Injectable PLLA is supplied as a sterile, freeze-dried powder with a shelf life of 2 years at room temperature. It requires reconstitution to form the highly viscous, particulate hydrogel that dictates injection with a 25-or 26-gauge needle. ...
... This injection technique for PLLA is performed using a 25-gauge 1-inch or a 26-gauge 0.5-inch needle inserted, bevel up, at a 30° to 45° angle at or below the level of the dermal subcutaneous junction. 15,19 There is decreased resistance with passage through the dense dermis into the yielding subcutaneous fat. At this level, the angle is reduced, and the needle is completely inserted to the hub and parallel to the skin surface. ...
... A retrograde thread of the volumizing agent is placed within each tunnel, and the volume is tapered as the needle approaches the pivot point to avoid excess accumulation and possible nodule formation at the pivot point. 15 Cross-fanning perpendicular to the original fanned tunnels may be performed as a modified version of cross-hatching. ...
Age-related volume loss; increased skin laxity, fat loss, and redistribution; and diminished support from underlying muscle and bone result in the observable and sometimes profound changes seen in the aging face. Aging also is associated with functional changes in the skin, such as dermal atrophy with diminished fibroblastic activity, decreased collagen production, and altered clastin. Dermal fillers, such as bovine, human, and purified porcine collagen; hyaluronic acids; calcium hydroxylapatite; and injectable medical devices (eg, poly-L-lactic acid), are used commonly for facial rejuvenation. Soft-tissue augmentation with fermal fillers and injectable medical devices has gained widespread acceptance as an alternative to more aggressive, invasive treatment of the aging face. Technique, knowledge, expertise with fillers, proper patient assessment, a well-formulated treatment plan with access to agents for superficial, moderate, and deep rhytides, and volume restoration provide the necessary ingredients for optimal soft-tissue augmentation while minimizing complications.
... It is also crucial to assess the effects of each previous series of injections to determine what refinements are needed before proceeding with additional treatment. This has been previously described in the literature as the 'treat-wait-assess' approach, and has been successfully applied in the correction of HIV-related facial lipoatrophy and for volume restoration in antiaging treatment (32,33). ...
... Our clinical experience with injectable PLLA suggests that three treatment sessions provide an optimal regimen for most immuncompetent patients. This practice is based on the treat-to-repair, wait-torestore and assess-to-refine concept (32,33), wherein each series of injections is believed to contribute to a foreign body response. Because each patient responds differently to treatment with injectable PLLA, it is important to allow sufficient time between treatments to avoid overcorrection of the original deficit. ...
... Isso inclui a correta reconstituição e hidratação do produto, a aplicação nas áreas específicas sob anestesia local e a massagem de toda a área injetada após o procedimento, garantindo correta dispersão do produto. 2,14,17,39,[50][51][52] O quadro 2 resume os pontos--chave no processo. ...
... Outros, ainda, aplicam gelo antes e após a injeção, para diminuir a dor, estimular a vasoconstrição e reduzir a formação de equimoses. 52 Deve-se fazer antissepsia da pele com clorexidine alcoólica a 2% a fim de evitar complicações infecciosas no pós-procedimento. ...
O conceito de rejuvenescimento facial abrange atualmente visão tridimensional, que reconhece
como sinais de envelhecimento não só a perda da textura cutânea e as rugas de expressão,
mas também as perdas volumétricas secundárias à remodelação óssea e a redistribuição
da gordura facial. O objetivo do presente artigo é apresentar uma revisão da literatura sobre
o ácido poli-l-láctico para rejuvenescimento facial, incluindo suas indicações, técnicas de
injeção, resultados esperados e possíveis efeitos adversos.
... This answers the use of Sculptra for the treatment of laxity. 7 Nonetheless, it is essential to remind ourselves that these fibroblast cells also produce elastic fibers and glycosaminoglycans. One of these glycosaminoglycans is the well-known, Hyaluronic Acid, a polysaccharide molecule responsible for the formation of gelatinous matrix along with the hydration of cutaneous tissue. ...
... It gradually replaces the loss of volume by stimulating fibroblasts which lay down new collagen. [19] The calcium hydroxyl apatite-based filler is a long-lasting synthetic semi-permanent dermal fillers. It acts as a scaffold for new tissue formation and stimulates collagen formation leading to thickening of the skin. ...
Facial aging is an ongoing biological process governed by both intrinsic and extrinsic factors. Conventionally, surgical treatments remained superior for decades due to satisfactory outcome. Expensive and invasive esthetic surgical procedures have been replaced by more affordable, less invasive procedures. For the past few years, novel nonsurgical treatment modalities are on the rise due to less patient morbidity and faster recovery. The intention of this article is to present a comprehensive review of the currently available nonsurgical methods to revert facial aging.
... [54][55][56][57] PLLA's marked ability to stimulate collagen production makes it ideal for targeting structural volume loss in multiple tissue layers, including deep dermal, subcutaneous, and bone-related deficits. [58][59][60][61] Mid-face volume restoration is achieved with the combination of a retrograde fanning technique in a subcutaneous plane to restore volume to the nasolabial and malar cheek fat compartments and supraperiosteal injection in the malar cheek to correct zygomatic bony resorption. 53,62 Supraperiosteal PLLA in the temporal concavities and subcutaneous fanning within the pre-auricular cheek restores volume to the lateral face. ...
Introduction:
Facial aging is a gradual process that involves a complex interaction of multiple factors including cutaneous photodamage and laxity, subcutaneous tissue volume loss, and bony resorption. These features have all been show to significantly improve with intense pulsed light (IPL), microfocused ultrasound (MFUS, Ultherapy), and poly-L-lactic acid (PLLA).
Methods:
To review the use of IPL, MFUS, and PLLA in combination with the treatment of facial aging.
Results:
Despite their extensive individual safety record, there is little data regarding combination therapy with these minimally invasive modalities.
Conclusions:
IPL, MFUS, and PLLA may be safely performed in a single treatment session to target multiple tissue planes concurrently without increased adverse events.
... It received approval from the Food and Drug Administration for the treatment of HIV-associated lipoatrophy in 2004 [13,14] and for cosmetic use in 2009 [2]. Sculptra is a volumizer lasting 18 to 24 months [15]. Sculptra 's longetivity is based on the low degradation kinetics of the PLLA microparticles, a result of irregularly shaped microparticles [3,16]. ...
Background: Wrinkles are characterized by changes in the organization and structure of the dermis. Human wrinkle fibroblasts (WF) have a different functional behaviour in comparison with normal-aged fibroblasts (NF). Decreases in migration capacities and collagen I synthesis are observed. Mitochondrial function is impaired with an increase in lac-tate production during aging. Sculptra® (poly-L-lactic acid: PLLA), a biodegradable synthetic polymer, is used for sub-cutaneous volume restoration. Thus we decided to investigate different fibroblast functions when placed in contact with PLLA. Objectives: The potential of PLLA to compensate for the reduction of metabolic activity, to restore the migra-tion capacity of WF and to inhibit the lactate production, was investigated and compared to NF. Methods: Two differ-ent skin samples were used from each of the three women’s facelift (one inside a face wrinkle and one from normal aged skin). Collagen I, lactate productions and proliferation capacities were investigated on monolayer cultures. Migra-tion properties were evaluated using three-dimensional collagen lattices. Results: PLLA increased collagen I synthesis, restored migration capacities and tended to decrease lactate production in WF, whereas PPLA stimulated proliferation in NF and tended to improve the migration of NF. Conclusion: These results suggested that PLLA from Sculptra® acted as a stimulus for collagen production in WF and that it is suitable for correcting skin depressions, such as wrinkles.
The ultimate goal of regenerative medicine is to repair, regenerate, or reconstruct functional loss in failed tissues and/or organs. Although regenerative medicine is a relatively new field, multiple diverse research groups are helping regenerative medicine reach its objectives. All endeavors in this field go through in silico, in vitro, in vivo, and clinical trials which are prerequisites to translating such approaches from the bench to the bedside. However, despite such promise, there are only a few regenerative medicine approaches that have actually entered commercialization due to extensive demands for the inclusion of multiple rules, principles, and finances, to reach the market. This review covers the commercialization of regenerative medicine, including its progress (or lack thereof), processes, regulatory concerns, and immunological considerations to name just a few key areas. Also, commercially available engineered tissues, including allografts, synthetic substitutes, and 3D bioprinting inks, along with commercially available cell and gene therapeutic products, are reviewed. Clinical applications and future perspectives are stated with a clear road map for improving the regenerative medicine field.
Este trabalho aborda brevemente o processo de envelhecimento facial para revisar e discutir a utilização dos bioestimuladores de colágeno empregados na harmonização orofacial visando o rejuvenescimento da face. Método: Foi pesquisado nas bases SciELO, BIREME e PubMed por artigos publicados até 2019, nos idiomas inglês e português. Os critérios de inclusão englobaram artigos originais que analisaram ou discutiram sobre os preenchedores cutâneos com capacidade bioestimuladora e o processo de envelhecimento facial; no total,72 artigos foram considerados elegíveis para esta revisão de literatura. Discussão: No mercado dermatológico existem quatro preenchedores cutâneos (ácido poli-L-láctico, hidroxiapatita de cálcio, policaprolactona e polimetilmetacrilato) que possuem a faculdade de estimular a neocolagênese a partir de uma resposta inflamatória subclínica localizada por parte do corpo do paciente. Cada produto possui suas particularidades quanto à composição, o tempo de início do efeito, e a durabilidade. De acordo com a literatura, todos os preenchedores cutâneos são considerados eficazes e seguros, podendo ser utilizados por profissionais devidamente capacitados. Conclusão: mesmo os bioestimuladores de colágeno sendo excelentes materiais capazes de prevenir ou reverter os efeitos do envelhecimento facial, não existe, porém, um bioestimulador dérmico perfeito, pois todos podem gerar efeitos adversos, devendo o profissional saber selecionar o produto ideal para o tratamento de cada paciente.
The poly-L-lactic acid (PLLA) injection technique stimulates neocollagenesis and provides a natural look. In recent years there has been a growing interest for using this in other body areas such as the neck, chest, back of hands, lower breast region, thoraco-axillary fold, buttocks, arms and medial thighs. Both in facial application as in the body, there is no consensus regarding the best dilution or application technique, and their descriptions mainly based on the authors experience. In this chapter will approach a new technique for body areas and the dilution of the quantity of the product per application. The application of PLLA for rejuvenation of body areas is a minimally invasive procedure, durable and low frequency of complications. The poly-l-lactic acid (PLLA) was approved in Europe in 1999 and approved in the United States in 2004 by the FDA for the treatment of facial lipoatrophy associated with human immunodeficiency virus (HIV). In 2009, FDA approved PLLA for cosmetic indication in immunocompetent patients [1, 2]. Over the past 20 years of experience, PLLA was safe and effective. It is a widely used and safe application to restore volume in facial aging and bofy sagging.
This article discusses the various nonsurgical treatments that can be performed in combination with facelift surgery to provide patients with a more complete facial rejuvenation. Nonsurgical adjuncts focus on facial volume enhancement, skin resurfacing, intense pulsed light for pigmentary changes, neuromodulators, and skin care in addition to the surgical techniques used to combat facial aging. Several options exist for skin resurfacing, including dermabrasion, chemical peels, and lasers; the advantages and limitations of each are discussed. Photographs demonstrating the effectiveness of nonsurgical treatments to facelift patients are displayed as examples of their powerful adjunctive effect.
For volumizing the aging face, few fillers display the versatility, endurance, and safety profile as autologous fat. Fat is the perfect choice for those patients wishing to add contour and projection to an otherwise flat visage. Understanding the concepts of facial volumetric aging is paramount to success with any filler but especially one as long lasting as autologous fat. In youth, facial contours are "balanced" with fat resplendent and diffuse. As the face ages, the fat becomes "unbalanced" and dependent on its overall body content. Recent anatomical research suggests that the face is made up of discrete separate fat compartments and that these compartments age individually. This is perfectly illustrated by comparing the atrophic aging seen all over in a patient of ascetic body type with the combination of hypertrophic and atrophic aging seen in a more corpulent individual. It appears that increasing body fat leads to deposits or hypertrophy of fat in certain fat compartments, while others remain atrophic (Figure 11.1A, B). It is unknown as to why the face ages compartmentally, but luckily, the transfer of autologous fat back into the atrophic areas can restore a sense of balance and youth to the face. PLANNING During the initial consult, it is helpful for patients to bring in a photograph of what they looked like ten years ago. It is important to ask the weight of the patient currently as compared with the time of the old photograph.
INTRODUCTION A wide variety of synthetic fillers are now available. Such fillers can be divided into a variety of categories. One descriptive category relates to filler duration. Fillers can last in the human body for short periods of time or they can be permanent. BioAlcamid® is a permanent prosthesis-type filler. It is used in many parts of the world but is not yet available in the United States. An ideal biomaterial must be nonallergic, inert, sterile nonpyogenic, noncancer producing, stable, incapable of migrating, and most importantly biologically compatible with the host tissue. The latter factor is required because it impacts on the ability of the filler to coexist with surrounding tissues without either stimulating the immune system or causing persistent inflammatory reactions. BIOALCAMID® BioAlcamid®, a synthetic polyalkylamide manufactured by Polymekon in Italy, is a permanent implant that fulfills some, but certainly not all, of the aforementioned requirements. CLINICAL STUDIES There are only a few studies that have evaluated the safety and efficacy of BioAlcamid® implants. In a clinical study performed by Protopapa et al., eighty BioAlcamid® implants were injected into seventy-three subjects aged sixteen to forty-eight years (forty females and thirty-three males). All patients were HIV+ and suffered from lipodystrophy syndrome to varying degrees. Individuals with uncompromised diabetes mellitus and psychiatric disorders and pregnant women were excluded from the study. No prior skin tests were done. Initial implants were placed in the face. Ultimately, three patients requested further corrections to their buttocks; four patients requested corrections to their limbs.
INTRODUCTION Dermal fillers have been available for more than 100 years, originally as injectable fat and more recently as biocompatible soft tissue fillers. The use of fillers has continued to increase in cosmetic surgery practices with the greater demands from patients for aesthetic improvement without surgery. This increase is secondary to not only the growing indications and availability of dermal fillers but also the desire for rejuvenation from a wider patient population among varying age groups and ethnicities. Currently available dermal fillers include porcine, bovine, and human collagens, hyaluronic acid (HA) preparations of animal or biosynthetic origin, poly-l-lactic acid products, polymethacrylate, and calcium hydroxyapatite. The use of soft tissue fillers is an attractive office procedure for providers because of the associated ease, cost, and minimal discomfort involved in treatment. Although the use of injectable soft tissue fillers is relatively safe, it is important to select patients carefully and counsel them appropriately to avoid complications. The process of informed consent is a crucial component of the relationship that must develop between the provider and the patient to minimize the already rare occurrence of legal complications. PATIENT SELECTION The media and manufacturer marketing has instilled views and expectations of complete rejuvenation of facial aging in patients by the use of fillers. Patient selection is important to have satisfied patients and reduce undesired outcomes. A thorough review of the history is the first step in this process.
INTRODUCTION There has been a paradigm shift in cosmetic surgery. We are now replenishing volume that has been depleted in the facial region as opposed to removing excess skin that remains. Facial lipoatrophy is a facet of a more general condition, lipodystrophy. It is a symptom of various conditions that include congenital disorders, HIV-related therapies, and aging. Because facial lipoatrophy, regardless of cause, is a disfiguring condition that affects many people, several devices have been used in an attempt to provide aesthetic correction for this condition. Some of these injectable devices include fat, collagen, hyaluronic acids, calcium hydroxylapatite, silicones, poly-L-lactic acid (PLLA), and polymers such as polymethyl methacrylate and polyacrylamide. Sculptra is a synthetic, biodegradable, and biocompatible injectable composed of PLLA. This is one of the few substances approved in Europe and in the United States for correction of lipoatrophy that has pending cosmetic uses. Injectable PLLA is a new class of devices that provides a semipermanent option to correct the visible signs of facial lipoatrophy. Sculptra was approved with CE Mark certification under the trade name New-Fill in Europe. It has been estimated that 150,000 patients in over thirty countries have been treated with New-Fill since 1999. Sculptra has been used to increase the volume of depressed areas, such as skin creases, wrinkles, folds, and scars. In 2004, PLLA’s approval was extended in Europe to include the large volume corrections of facial lipoatrophy.
INTRODUCTION As the armamentarium of fillers for soft tissue augmentation expands, physicians and patients continue to seek those that approach criteria for the "ideal filler." Regardless of treatment area, the ideal filler would demonstrate versatility, biocompatibility, consistency of results, a natural feel, an excellent safety profile, and a superb cost-to-benefit ratio. Furthermore, it would be easy to inject, have minimal side effects, and not require allergy testing. The ideal filler would also achieve some degree of longevity and, arguably, permanence. Liquid injectable silicone (LIS) is the original permanent, synthetic soft tissue-augmenting filler that may be employed for a variety of cutaneous and subcutaneous atrophies. Used worldwide for at least forty years, it distinctively meets a majority of the criteria that would define the ideal filler, including versatility, reliability of results, a natural feel, and an excellent cost-to-benefit ratio. When LIS is appropriately administered with the microdroplet serial puncture technique, patients may obtain enduring correction of scars, rhytids, and depressions, as well as lasting augmentation of lips and other facial contour atrophies and deformities. However, the "permanence" of LIS refers to the enduring nature of the product in vivo rather than a "permanent" cosmetic result. Although the progressive tissue volume loss of aging will continue to occur, the degree of correction due to placement of LIS will persist. For this reason, silicone and other permanent fillers are much less forgiving than temporary fillers, in that overcorrection or undesired augmentation will also persist. Hence, experience and precise technique are prerequisites to favorable patient outcomes.
INTRODUCTION The demand for safe, effective, long-lasting, and biocompatible dermal filler materials is increasing as a growing number of patients seek minimally invasive options for aesthetic improvement. For a substance or device to be amenable for soft tissue augmentation, in addition to producing the desired cosmetic results, the product must be well tolerated, exhibit a minimum of undesirable reactions, and be nonteratogenic, noncarcinogenic, and nonmigratory. In addition, the material or device must be easy to use and provide predictable, persistent correction through reproducible implantation techniques. Finally, in the United States, the Food and Drug Administration (FDA) review and approval of such products not only substantiates they meet safety and efficacy requirements but also assures adherence to important manufacturing and product labeling requirements postapproval. Numerous attempts have been made to develop safe biological (e.g., collagen, hyaluronic acid) or synthetic (man-made) materials to fill unwanted wrinkles and scars. Currently, in the United States, there are about twelve or more different soft tissue fillers approved for cosmetic use; in Europe, there are approximately eighty CE marked approved cosmetic fillers with many more available worldwide. Historically, biologic filler materials that use "natural-based" core substances such as collagen and hyaluronic acid materials have predominated the marketplace. These materials, whether they are derived from a bioengineered or extracted from a natural source, typically have been modified to improve tolerability (e.g., removal of impurities) and modified to improve durability (e.g., cross-linked).
INTRODUCTION In the last five years, there has been an increased demand in the number of fillers available in the market. This corresponds with the increased demand for less-invasive procedures among consumers. The result is a wide array of choices for the patient and injector to address almost any type of problem. In this chapter, we outline the various applications of fillers throughout the body. BACKGROUND The ideal injectable filler remains elusive to this day. The properties we look for in an ideal injectable filler include safety, ease of use, consistency of results, and longevity of results. Liquid silicone was the first filler available to treat contour defects, scars, and rhytids of the face. It was widely used for two decades until concerns about long-term safety caused it to fall out of favor. Several years ago, a new liquid silicone product was cleared by the FDA and has been used in an "off-label" fashion for cosmetic enhancement of the face. Liquid silicone is a permanent filler. Bovine collagen was the second available injectable filler and was widely used with a very low incidence of complications. Allergy testing of the skin was necessary with Zyderm and Zyplast. These products lasted for a few months after injection, requiring frequent administration. Over the years, collagen-based products have evolved. Cosmoderm and Cosmoplast (human collagen) eliminated the need for skin testing. Evolence (porcine collagen) is cross-linked, giving it a longer-lasting quality, and it does not require skin testing. Autologous fat transfer techniques were introduced around the same time as bovine collagen.
INTRODUCTION The skin’s natural aging process manifests itself in the form of contour changes, wrinkles, the depletion of subcutaneous fat, and the loss of dermal collagen and elastin. Today’s patients are seeking skin rejuvenation to achieve a natural and youthful appearance through minimally invasive procedures with no downtime. Thinning of the lips and deepening of the nasolabial folds and marionette lines are common manifestations of the aging process. Despite multiple treatment modalities and advances in cosmetic surgery, long-lasting, natural-looking augmentation in these areas continues to present a challenge. Available since January 1, 2001, Advanta expanded polytetrafluoroethylene (ePTFE) implants (Ocean Breeze Surgical, Amherst, NH) have been used successfully for augmentation of thinning lips, deep nasolabial folds, and marionette lines without the risk, recovery time, and expense of major surgery. DESCRIPTION OF THE ADVANTA ePTFE IMPLANT Advanta ePTFE implants are an expanded porous polytetrafluoroethylene material with a unique dual- porosity structure. ePTFE is a stable polymer of carbon atoms with a coating of fluorine atoms. The unique dual-porosity structure has a soft high-porosity 100-µm central core surrounded by a smooth, medium-porosity 40-µm outer core. This unique dual-porosity concept promotes tissue integration, vascular ingrowth, and stability. This is critical in preventing migration and reducing shrinkage. The dual-porosity structure is also responsible for a soft feel giving it natural-looking results. Advanta ePTFE implants are available in sheets and geometrical shapes with and without reinforcement. The implants are either round or oval (Figure 9.1).
INTRODUCTION With the unprecedented rise in the use of injectable fillers, an increasing number of patients are approaching their physicians to undergo soft tissue augmentation. It is absolutely essential to educate patients about the procedure, its potential benefits, and its potential complications. As always, this should be done prior to the procedure to be most effective. Detailed pre- and postprocedure instructions are an essential part of this education process. It is this education that ultimately empowers patients and helps them to achieve their ideal cosmetic outcome. Effectively written pre- and postprocedure instructions serve multiple important functions in educating patients regarding their cosmetic procedures. First and foremost, the instructions help patients to understand what to expect from the procedure. Second, they educate patients regarding potential adverse events and possible complications from procedures. Third, they educate patients regarding potential medications and activities that may compromise the postprocedure period or even the cosmetic outcome of the procedure. Finally, they allow the physician to instruct the patient in the management of simple and common postprocedure issues and events that may occur. In order for these instructions to be of the most benefit, it is essential that they be written in layman’s terms. Instructions with complex medical terminology will only serve to confuse the patient, increase their anxiety regarding the procedure, and decrease their likelihood of achieving their desired outcome. The instructions should always be reviewed prior to the procedure with the patient.
INTRODUCTION Slowing down the inevitable course of skin aging has been a popular notion for hundreds of years. Ancient Egyptians compounded early chemical peels using the lactic acid in milk and performed an early form of microdermabrasion with salt, alabaster, and animal oils. More sophisticated methods including soft tissue augmentation with autologous fat were first reported in the German literature by Neuber in 1893. The first U.S. Food and Drug Administration (FDA)-approved filler was bovine collagen (Zyderm I) in 1981. Since then, a myriad of soft tissue fillers have been introduced. These include both bovine and human collagens (Zyderm, Zyplast, CosmoDerm, and CosmoPlast), hyaluronic acids (Restylane, Perlane, Juvederm, and Hylaform), calcium hydroxyapatite (Radiesse), poly-l-lactic acid (Sculptra), and synthetic polymers such as liquid silicone and Artecoll or Artefill. These procedures have gained popularity as they are generally safe in experienced hands, and many show rapid improvement yielding high levels of clinical satisfaction. All cosmetic procedures have associated risks. As the incidence of soft tissue augmentation has increased, as would be expected, adverse effects have been reported more commonly. In a survey of 286 patients, McCraken et al. recently reported a 5 percent complication rate among ophthalmologists performing soft tissue augmentation procedures. This article will emphasize the prevention, identification, and treatment complications with a focus on temporary fillers. Permanent fillers (such as Artecoll) permit greater longevity with which comes the greater risk of adverse sequelae. These permanent substances present a greater risk of causing late-onset (>one year) granulomas.
INTRODUCTION Presently, there is no one ideal filler for all patients, for all indications, and in all situations. It is unlikely that this will ever occur, given the extreme variables in patients and in the goals of aesthetic filler injections. The type of product best for lip injection may not be the best for volumetric cheek filling or for dorsal hand augmentation. The injectable filler best for a young woman with fine skin texture is different than that for an older man with redundant folds or for acne scars. The cost of material, duration of effect, and the social downtime issue all play a role in making the final decision of product choice. In the end, it is the technical skill of the physician and the familiarity with the product that are the most important factors in the clinical result. This discussion will review the key issues to help the practicing aesthetic physician choose the ideal FDA (Federal Drug Association) approved filler for each patient. Fillers that have not been FDA approved in the United States, autologous fat (an excellent global restorative filler), and silicone (an excellent permanent filler for HIV lipotrophy) will not be discussed here. CHARACTERISTICS OF THE IDEAL FILLER The ideal filler is nonallergenic, durable yet reversible, has a natural look and feel after injection, is able to be injected in off-face areas, and is very safe. It should be easy to inject and should cause only little pain, swelling, or bruising.
INTRODUCTION Synthetic particulate-based materials are notable for their ability to provide a robust and durable implant and have long been used as bulking agents in a variety of surgical and nonsurgical settings. Radiesse® (BioForm Medical, Inc., San Mateo, CA) is an injectable filler material composed of synthetic calcium hydroxylapatite (CaHA) microspheres suspended in an aqueous carrier gel. Seventy percent of the composition of Radiesse is sodium carboxymethylcellulose carrier gel; the remaining 30 percent of the composition is CaHA microspheres. These uniform microspheres (25-45 microns) are identical in composition to the mineral portion of human bone and teeth. CaHA has been used for over twenty years in various forms in plastic and reconstructive surgery, otology, otolaryngology, neurosurgery, orthopedic surgery, maxillofacial surgery, and dentistry. The excipients that comprise the aqueous gel carrier (i.e., cellulose, glycerin, and sterile water) are classified as "Generally Recognized as Safe" (21 CFR 182) by the Food and Drug Administration and have an extensive record of use in intramuscular injectable products such as Cortone®, Decadron®, and Dalalone®. The components of CaHA occur naturally in the body and therefore are inherently biocompatible. Results from extensive in vitro and in vivo safety studies, including toxicology assessments, standardized biocompatibility testing, and a three-year animal study, demonstrate that injectable CaHA is biocompatible, nontoxic, nonirritating, and nonantigenic. Because CaHA contains no animal or human tissue derivatives, patient sensitivity testing is not required before use.
The present treatise has outlined the major advances in the development and utilization of fillers in the United States. Fillers are playing an ever-expanding role within this clinical setting. Combination programs employing toxins, fillers, light source, and radiofrequency technologies make up the backbone of noninvasive photorejuvenation programs. The therapeutic armentarium of fillers available in this country continues to evolve annually. There are six major trends in next-generation fillers that have evolved in this regard. A well-accepted and standardized classification schema of these agents has yet to be evolved. LONGER ACTING FILLING AGENTS There is definitely a trend toward longer acting fillers. In our busy world and for economic reasons, individuals would like to minimize the number of filler treatments that are necessary while still maintaining effect. The major question that is not universally accepted is what is that optimal duration of effect? Most physicians feel that an intermediate-acting filler with duration of twelve to eighteen months is optimal. This allows for longevity greater than older generation collagens and traditional hyaluronic acid derivatives; however, if there are adverse sequelae, it will resolve within a reasonable period of time, although one may expect as we move down the road that this timeline may continue to expand. SITE-SPECIFIC FILLERS Another major trend in fillers is specific capabilities. This means that they have clinical and physical characteristics that are uniquely beneficial for given anatomic areas. Examples of such site-specific areas are the lips and tear troughs, where lighter fillers with greater laminar flow characteristics would be more beneficial.
INTRODUCTION Dermal filling agents and botulinum neurotoxin are currently widely utilized for facial augmentation and global restoration of the aging face. For years, the conventional wisdom regarding dermal injectables for facial rejuvenation was "Botox for the upper face; Fillers for the lower face." However, cosmetic dermatologists have advanced from the practice of treating single lines and wrinkles toward filling large facial areas to globally restoring natural facial contours (Ditre, 2008). Cosmetic dermatologists now have a better understanding of the facial aging process, and as new fillers become available, there is an increased recognition that when treating the aging face, the combination of soft tissue augmentation and botulinum toxin takes part in principal roles to fill, lift, tighten, and relax rhytids. OVERVIEW OF INJECTABLE DERMAL FILLERS Over the last four years, the US Food and Drug Administration (FDA) has approved many dermal filling agents. European countries and South America have had numerous dermal filling agents available for several years. Therefore, it can be quite difficult to decide what filler to use and where the filler should be injected. Injectable dermal fillers can be grouped according to their degree of degradability. In general, fillers may be classified into biodegradable and nonbiodegradable products. The degradable material may be further classified into xenografts (derived from another species such as bovine collagen or hyaluronic acid of bacterial or avian origin), autografts (from the same person, such as autologous fat), and synthetic products (PLLA and CaHA) (Jones, 2007, p. 106).
EMERGENCE OF HYALURONIC ACIDS As we age, the underlying connective tissue responsible for the skin’s youthful elasticity and fullness degenerates. This degeneration is exacerbated by several factors, especially sun exposure and repeated use of underlying muscles. These factors are particularly evident in facial skin. Crow’s feet, laugh lines, and smile lines are among the most common cosmetic complaints. Consequently, a fervent desire exists to employ effective and safe cosmetic treatments to bolster the underlying tissue and mitigate these changes. Injectable fillers have proven to be an effective method of achieving this goal. The first FDA-approved cosmetic filler that generated substantial enthusiasm was collagen. These products, though effective, had substantial drawbacks, including limited longevity and concerns for allergic reaction. The demand for a filler that not only bypassed the need for allergy testing but also offered greater longevity inspired the development of additional fillers, notably hyaluronic acid agents. In December 2003, Restylane became the first FDA-approved hyaluronic acid product offered in the United States, and several others have since followed or are pending approval. Aside from longevity and low allergenicity, these newer fillers offer other advantages. Particularly valuable are their inherent ability to bind large amounts of water to further bolster rhytids and cosmetic effect. EXAMPLES OF HYALURONIC ACIDS Clinicians use several varieties of hyaluronic acids, including FDA-approved agents such as Restylane, Perlane, Juvederm, Hylaform, Hylaform Plus, Captique, Elevess, and Prevelle Silk. Other hyaluronic acid products, many of which are already used internationally, are expected to be approved by the FDA in the near future.
The poly-l-lactic acid (PLLA) injection technique stimulates neocollagenesis and provides a natural look. In recent years there has been a growing interest for using this in other body areas such as the neck, chest, back of the hands, lower breast region, thoraco-axillary fold, buttocks, arms, and medial thighs. There is no clear consensus regarding the best dilution or application techniques for the face and the body, and the description in this article is based on the authors’ experience. In this chapter I will approach a new technique for body areas and the dilution of the quantity of the product per application. The application of PLLA for rejuvenation of body areas is a minimally invasive procedure, with durable and low frequency of complications.
Poly-L-lactic acid (PLLA) is a biocompatible, re-absorbable, immunologically inert polymer that induces neocollagenesis through a subclinical inflammatory response. It is indicated for restoration of facial volume associated with facial lipoatrophy in immunocompetent or HIV-immunodeficient patients. In addition there are cosmetic indications for extra facial areas. For more than three decades it has been used in medical devices such as plates, screws, intraosseous and soft tissue implants, and as a biodegradable vector for drugs, in sutures and stents. The present article is aimed at presenting a literature review on the indications, application method, and complications of the use of PLLA.
The use of temporary fillers continues to grow as the understanding of restoring a youthful appearance expands. Improving the signs of aging using only surgical techniques has transitioned to treatment of soft tissue atrophy with volume replacement. Temporary fillers have given many patients a lower cost, less permanent introduction into optimizing their appearance at any age. In this article, we explore the history of temporary fillers and the current types that are available. We also highlight the expanding use of injectable fillers in the upper face and periorbital area.
Background:
Aging of the face, neck, and décolletage is a multifactorial process involving epidermal photodamage and loss of soft tissue and bony volume. Multilevel rejuvenation of these areas can be obtained by enhancing volume restoration, neocollagenesis, and tissue contraction with combined efficacy of poly-L-lactic acid (PLLA) and microfocused ultrasound (MFU, Ultherapy) treatments.
Methods:
The authors reviewed the use of PLLA and MFUs as collaborative modalities to improve the appearance of the face, neck, and décolletage.
Results:
Experienced cosmetic dermatology centers deliver PLLA and MFU in a single session to target multiple tissue planes.
Conclusions:
Concurrent treatment with PLLA and MFUs can be performed efficiently and safely; however, additional research is needed to explore the synergistic effects of these treatments. Patients may also benefit from decreased overall downtime and necessary office visits.
Injectable fillers have become a prevalent means of facial rejuvenation and volume expansion. While typically well tolerated, serious complications have been reported. The authors present a case in which an otherwise healthy female with a history of multiple filler injections including poly-L-lactic acid, developed 3 weeks of neuropathic pain in the left temporal fossa following injection. To the best of the authors knowledge, neuropathic pain has not been reported as a complication following poly-L-lactic acid injection. The patient was treated with an injection of steroid and long-acting anesthetic with resolution of symptoms.
Die Nachfrage nach minimal-invasiven ästhetischen Eingriffen steigt von Jahr zu Jahr mit einer rasanten Geschwindigkeit. Neben Botulinumtoxin und Laserbehandlungen stellt die Unterspritzung mit Dermalfillern eine der wichtigsten Methoden dar. Dermalfiller können für zahlreiche Behandlungsindikationen eingesetzt werden: Falten (feine bis tiefe), Lippenaufbau, Gesichtsdeformitäten, eingesunkene Narben, HIV-assoziierte Lipoatrophie, an Händen, Hals und Dekolletee. Derzeit sind über 160 Dermalfiller im Handel. Sie unterscheiden sich stark in Ursprung (eigen- oder fremdhuman, tierisch, fermentativ oder synthetisch), Dauer des Effekts und Abbauverhalten (temporär, semipermanent, permanent), Injektionstiefe (dermal, subkutan, supraperiostal) sowie Risikoprofil. Ärzte, die Dermalfiller einsetzen, sollten eine genaue Kenntnis dieser Eigenschaften sowie der anatomischen Gegebenheiten im Behandlungsareal haben. Dies ist für den korrekten Einsatz und ein optimales ästhetisches Ergebnis essenziell. Vor jeder Behandlung sollten der Ablauf der Behandlung, gewünschte Effekte, Haltbarkeit und potenzielle Risiken des einzusetzenden Fillers mit dem Patienten diskutiert werden. Die Auswahl des Dermalfillers, die Injektionstechnik und das eingesetzte Volumen richten sich nach der anatomischen Lokalisation, der Art des Defekts, dem gewünschten Effekt und der Erfahrung des Arztes.
BACKGROUND: The persistence of dermal fillers containing crosslinked hyaluronic acid (XLHA) correlates linearly to the concentration of polymer in solution. For dermal fillers composed of XLHA, a polymer concentration above approximately 25 mg/mL is not practical because it cannot be easily injected through a small-bore needle. OBJECTIVE: Formulating dermal fillers from mixtures of carboxymethylcellulose (CMC) and polyethylene oxide (PEO) has several advantages over XLHA. We hypothesize that increasing the concentration of CMC/PEO will increase the persistence in the dermis. These polymers of CMC and PEO can be formulated at higher concentrations than XLHA to produce smooth, particulate-free gels resulting in easier, more controllable injection. Second, these gels are not required to be covalently crosslinked; CMC/PEO forms a stable gel-like structure in solution without crosslinking. Materials and Methods: Here we have prepared dermal fillers from CMC/PEO polymer blends at concentrations of 20 mg/mL (dermal filler 1), 29 mg/mL (dermal filler 2), 37 mg/mL (dermal filler 3), and 45 mg/mL (dermal filler 4) and measured their rheologic properties compared to commercial XLHA dermal fillers. RESULTS AND CONCLUSIONS: The data here demonstrate that it is possible to duplicate the rheologic properties of commercial XLHA fillers using CMC/PEO at different polymer concentrations to formulate improved dermal fillers. All of the dermal filler formulations prepared can be easily injected through 30-gauge needles.
There is a plethora of medical aesthetic treatments on the market, all of which claim to stimulate varying degrees and types of collagen production in the body. For some modalities, hypotheses are reasonable with a well-established correlation in their use and visible signs of improvement to the condition of the skin; however, many are questionable in their evidence base and ability to stimulate true collagenesis with any significant long-term treatment outcomes. The aim of this paper is to offer a brief, balanced overview of a selection of collagen-stimulating modalities available today in the UK's aesthetic medicine arena. The article will also reveal how many existing collagen-stimulating modalities are reliant and driven by the body's inflammatory response to injury, and subsequently the wound healing cascade of events that follow. The author will also review the data underpinning each modality and interpret clinical findings in comparison to experiential findings in everyday practice. Short-term versus long-term benefits to patients will also be discussed, as well as the associated risk factors.
Objectives
To ascertain by MRI the presence of filler injected into facial soft tissue and characterize complications by contrast enhancement.
Methods
Nineteen volunteers without complications were initially investigated to study the MRI features of facial fillers. We then studied another 26 patients with clinically diagnosed filler-related complications using contrast-enhanced MRI. TSE-T1-weighted, TSE-T2-weighted, fat-saturated TSE-T2-weighted, and TIRM axial and coronal scans were performed in all patients, and contrast-enhanced fat-suppressed TSE-T1-weighted scans were performed in complicated patients, who were then treated with antibiotics. Patients with soft-tissue enhancement and those without enhancement but who did not respond to therapy underwent skin biopsy. Fisher’s exact test was used for statistical analysis.
Results
MRI identified and quantified the extent of fillers. Contrast enhancement was detected in 9/26 patients, and skin biopsy consistently showed inflammatory granulomatous reaction, whereas in 5/17 patients without contrast enhancement, biopsy showed no granulomas. Fisher’s exact test showed significant correlation (p 10 mm) was found in 16 complicated patients (65 %; levels IA/IB/IIA/IIB).
Conclusions
MRI is a useful non-invasive tool for anatomical localization of facial dermal filler; IV gadolinium administration is advised in complicated cases for characterization of granulomatous reaction.
Key Points
• MRI is a non-invasive tool for facial dermal filler detection and localization.
• MRI-criteria to evaluate complicated/non-complicated cases after facial dermal filler injections are defined.
• Contrast-enhanced MRI detects subcutaneous inflammatory granulomatous reaction due to dermal filler.
• 65 % patients with filler-related complications showed lymph-node enlargement versus 31.5 % without complications.
• Lymph node enlargement involved cervical levels (IA/IB/IIA/IIB) that drained treated facial areas.
PURPOSE
Cosmetic tissue augmentation and correction of skin depression using injectable material is a constantly growing worldwide non-surgical procedure. The aim of our study was to investigate and describe the MR aspects of diverse temporary and permanent dermal fillers injected in subcutaneous tissue of the face.
METHOD AND MATERIALS
We have evaluated with MRI 10 normal volunteers undergone injection of temporary dermal fillers in the previous 4 months preceding the exam and another 9 who underwent injection of permanent dermal fillers in the previous 2-3 years. 9 patients with local complications after the injection of permanent fillers were also evaluated with MRI. All the exams were performed with a 1.5T superconductive magnet using Gradient-Echo T1-weighted, FSE T2-weighted with or without fat saturation (TI=150ms) on axial plane with a slice thickness of 3 mm. We also performed TIRM sequences using a TI of 130 ms, specific for silicone material and in all the patients with local complications axial FSE T1-weighted scans with fat-saturation after the i.v injection of a paramagnetic contrast agent were acquired.
RESULTS
In all the normal volunteers it was possible to visualize the filler in the facial subcutaneous soft tissue. T2-weighted scans with fat saturation showed the best contrast to noise ratio and was considered the best MR acquisition in the evaluation of dermal fillers. In complicated cases it was possible to detect a diffuse edema at the site of the injection in 4 patients visualized on T2-weighted scans with fat saturation and in 2 patients a diffuse contrast enhancement of the subcutaneous tissues was detected due to an active inflammatory process.
CONCLUSION
MRI has proved to be a useful tool in the identification of subcutaneous facial filler injection for cosmetic purposes and in the evaluation of possible soft tissue adverse reactions.
CLINICAL RELEVANCE/APPLICATION
MRI has proved to be a useful tool in the identification of subcutaneous facial filler injection for cosmetic purposes and in the evaluation of possible soft tissue adverse reactions.
Aging is a complex process involving both genetically determined and environmental factors that result in functional and aesthetic changes in the skin, soft tissue, and skeletal support structures. These age-related changes are particularly apparent on the human face. In recent years, there has been increasing interest in reversing the effects of these age-related changes to restore a youthful appearance and improve patients' self-perception. Although many nonsurgical treatments for aesthetic correction of facial aging focus on skin restoration and removal of the effects of photoaging on the skin, other treatments, such as dermal fillers, address the soft-tissue volume loss that underlies many of the effects of aging. Advances in cosmetic dermatology, particularly in the area of soft-tissue augmentation, have expanded the options for older patients seeking to improve their facial appearance.
The use of dermal fillers for soft-tissue augmentation has increased greatly in recent years, as patients seek nonsurgical and less invasive options for facial rejuvenation. Since the United States Food and Drug Administration approval of bovine collagen in 1981, the number of dermal fillers available for restoration of age-related facial volume loss has expanded considerably. The most widely used primary components of dermal fillers include bovine and human collagens, hyaluronic acids, polymethylmethacrylate, and autologous fat. Although these agents produce satisfactory short-term or long-lasting cosmetic results, they are merely space-filling agents and do not address the age-related changes in collagen synthesis and activity that underlie the volume loss characteristic of the aging face.
Die Nachfrage nach minimal-invasiven ästhetischen Eingriffen steigt von Jahr zu Jahr mit einer rasanten Geschwindigkeit. Neben Botulinumtoxin und Laserbehandlungen stellt die Unterspritzung mit Dermalfillern eine der wichtigsten Methoden dar. Dermalfiller können für zahlreiche Behandlungsindikationen eingesetzt werden: Falten (feine bis tiefe), Lippenaufbau, Gesichtsdeformitäten, eingesunkene Narben, HIV-assoziierte Lipoatrophie, an Händen, Hals und Dekolletee. Derzeit sind über 160 Dermalfiller im Handel. Sie unterscheiden sich stark in Ursprung (eigen- oder fremdhuman, tierisch, fermentativ oder synthetisch), Dauer des Effekts und Abbauverhalten (temporär, semipermanent, permanent), Injektionstiefe (dermal, subkutan, supraperiostal) sowie Risikoprofil. Ärzte, die Dermalfiller einsetzen, sollten eine genaue Kenntnis dieser Eigenschaften sowie der anatomischen Gegebenheiten im Behandlungsareal haben. Dies ist für den korrekten Einsatz und ein optimales ästhetisches Ergebnis essenziell. Vor jeder Behandlung sollten der Ablauf der Behandlung, gewünschte Effekte, Haltbarkeit und potenzielle Risiken des einzusetzenden Fillers mit dem Patienten diskutiert werden. Die Auswahl des Dermalfillers, die Injektionstechnik und das eingesetzte Volumen richten sich nach der anatomischen Lokalisation, der Art des Defekts, dem gewünschten Effekt und der Erfahrung des Arztes.
The availability and variety of different injectable modalities has led to a dramatic increase in soft tissue augmentation procedures in recent years. Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable polymer device approved in the United States for use in immunocompetent patients as a single regimen of up to four treatment sessions for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. Injectable PLLA is also approved for restoration and/or correction of signs of facial fat loss (lipoatrophy) in individuals with HIV.
The present article provides an overview of previous studies with injectable PLLA, and specifically focuses on the number of recommended treatment sessions and intervals between treatment sessions. The authors also provide two case studies to support their recommendations for an average of three treatment sessions.
Although the specific mechanisms remain hypothetical, injections of PLLA are believed to cause a cascade of cellular events that lead to collagen repair and subsequent restoration of facial volume. Because the development of a response to injectable PLLA is gradual and its duration of effect is long lasting, sufficient time between treatment sessions should be allocated to avoid overcorrection.
Studies of injectable PLLA support the hypothesized mode of operation, and the experience and clinical recommendations of the authors that suggest that three treatment sessions are an optimal regimen for use of injectable PLLA in the majority of patients.
The demand for minimally invasive cosmetic procedures is increasing rapidly every year. In addition to botulinum toxin and laser treatments, the injection of dermal fillers is one of the most relevant methods. Dermal fillers can be used for a multitude of indications: wrinkles (fine to deep), lip augmentation, facial deformities, sunken scars, and HIV-related lipoatrophy in hands, neck and décolleté. There are currently 160 dermal fillers on the market. They differ greatly in terms of origin (own or cadaveric-derived, animal, bacterial fermentation or synthesis), duration of the effect and breakdown properties (temporary, semi-permanent, permanent), injection depth (dermal, subcutaneous, supraperiosteal), and risk profile. Physicians who administer dermal fillers should have a thorough knowledge of their characteristics and of the anatomy of the area to be treated. This is essential for correct administration and optimal aesthetic results. Prior to any treatment, details of the procedure, the desired effects, durability, and potential risks of the filler to be injected should be discussed with the patient. The choice of dermal filler, the injection technique, and the volume to be administered are determined according to the anatomic site, the type of defect, the desired effect, and physician experience.
Injectable soft tissue fillers play an important role in the aesthetic treatment of the ageing face. Staving off wrinkles and folds accounts for the most popular minimally invasive procedures performed.
Since the acceptance of collagen as a filler in 1977, new reabsorbable and non-reabsorbable implants have appeared with varying degrees of success. Most of the early dermal-filling materials, of historical interest, were potentially long lasting, even permanent. Today, as we know more about products and their potential complications, a more accurate treatment plan can be arranged for the patient.
The ideal desired characteristics for a soft tissue filler are that they must be safe, biocompatible, easy to inject, readily prepared, easy to store, affordable, have long lasting cosmetic effect, and not provoke any complications. In this chapter, we go through the history of dermal-filling materials, mentioning the most important biodegradable, semipermanent, and nonbiode-gradable fillers. Technical guidelines are given. The conclusion is that today injectable fillers based on hyaluronic acid hold many of the sought-after properties of the ideal filler and please patients' demand for products with little associated risk. Nonbiodegradable fillers can give a definitive correction but involve the risk of severe and permanent adverse reactions.
Learning objectives:
After studying this article, the participant should be able to: 1. Describe the most common options available for minimally invasive facial rejuvenation. 2. Identify key elements essential to each treatment option. 3. Know how to avoid and manage complications for these procedures.
Summary:
Minimally invasive cosmetic procedures continue to increase in popularity. This article is intended to provide a broad and practical overview of common minimally invasive cosmetic techniques available to the plastic surgeon.
Loss of facial volume due to skeletal resorption and facial fat redistribution is considered a primary cause for increased skin folding and sagging associated with aging. The objective of this review is to examine how use of injectable poly-L-lactic acid (PLLA) for correction of human immunodeficiency virus (HIV)-associated facial lipoatrophy supports wider use in treating aging-related facial changes given its approval for aesthetic use. A literature review of studies evaluating injectable PLLA for the treatment of HIV-associated or aging-related contour deficiencies was conducted via MEDLINE, supplemented by the author's clinical experience. In clinical trials of HIV-related facial lipoatrophy, injectable PLLA increased dermal thickness for up to 96 weeks. Another study showed significant improvements in aging-related nasolabial fold wrinkles that lasted up to 25 months. Understanding differences in the use of injectable PLLA between patients with HIV and those with aging-related facial changes will help physicians optimize patient treatment.
IgG4-related ocular adnexal disease, a relatively recently described clinical entity, is important to diagnose because during the acute phase, it responds favorably to corticosteroid treatment. The diagnosis can be confirmed by simple blood tests and histology. IgG4-related dacryoadenitis and generalized orbital disease have been reported; however, this is the first report of IgG4-related disease of the lacrimal sac. We describe an 80-year-old female who presented with a painless erythematous indurated swelling in the right lacrimal sac area with complete obstruction of the right nasolacrimal system. A 9-mm lacrimal sac mass was noted on CT dacryocystogram. Blood tests revealed an elevated serum IgG4 level, and the lacrimal sac histology was characteristic of IgG4-related disease. Corticosteroid treatment was declined by the patient. She was kept under close observation for signs of progression, systemic involvement, and potential malignant transformation.
Visual loss following esthetic treatment of the face is a rare but devastating iatrogenic complication. The authors report a case of a 43-year-old man with blindness and ophthalmoplegia of the left eye following a treatment of the left periorbital region with the subcutaneous filler poly-(L)-lactic acid. The patient's symptoms began immediately following one of the tunneled injections. On presentation, the patient had clear signs of ocular and orbital ischemia. Angiography and further history suggested an embolic orbital infarction as the mechanism of injury. The increased usage of subcutaneous fillers for facial rejuvenation had introduced a small but proven risk of embolization of these viscous materials to the eye and orbit.
'Lipodystrophy syndrome' in the setting of HIV infection has come to encompass a collection of morphological and metabolic abnormalities linked with the use of antiretroviral therapy and other risk factors. We review the clinical literature on this subject as it has evolved historically, taking pertinent methodological issues into account.
Clinical research has indicated that the use of nucleoside reverse transcriptase inhibitor (NRTI) and HIV protease inhibitor (PI) therapy is associated with a risk of long-term toxicity syndromes, and that the aetiopathogenesis of these adverse effects is independent of the antiretroviral effects of these drugs. In relation to the lipodystrophy syndrome, it appears that the most powerful determinant of subcutaneous fat wasting is an interaction between these two drug classes. In this review, possible mechanisms underlying the contributions of both PI and NRTI drugs are reviewed, with an emphasis on their effects on adipose tissue. On this basis, an 'adipocentric', or minimal model of the syndrome is developed, in which divergent effects at the adipocyte of NRTIs (mitochondrial toxicity) and PIs (insulin resistance and impaired adipocyte maturation) interact to produce a phenotype that is consistent with clinical observations.
Background: In the absence of currently available therapy to manage facial lipoatrophy, strategies used to compensate for facial fat loss warrant clinical evaluation. Methods: The goal of this open-label, single-arm, pilot study was to evaluate the efficacy and safety of facial injections of poly-L-lactic acid (PLA) (New-Fill)® in HIV-infected patients with severe facial lipoatrophy. Patients received four sets of injection at day 0 and then every 2 weeks for 6 weeks. Patients were evaluated by clinical examination, facial ultrasonography, and photography at screening and at weeks 6, 24, 48, 72, and 96. Results: Fifty patients were enrolled. At entry, the median facial fat thickness was equal to zero (range, 0.0–2.1 mm). The median total cutaneous thickness (TCT) increased significantly from baseline : +5.1 mm (range, 2.2–8.6 mm) at week 6, +6.4 mm (range, 3.1–9.1 mm) at week 24, +7.2 mm (range, 4.2–9.6 mm) at week 48, +7.2 mm (range, 3.5–9.6 mm) at week 72 and +6.8 mm (range, 3.9–10.1 mm) at week 96 (P < 0.001). The proportion of patients with TCT > 10 mm was observed in 19% at week 6, 41% at week 24, 61% at week 48, 52% at week 72 and 43% at week 96. In 22 (44%) patients, palpable but non-visible subcutaneous micronodules were observed with a spontaneous resolution in six patients at week 96. Conclusion: The benefit of PLA for the correction of the facial lipoatrophy in HIV-infected patients was clearly demonstrated, with an evident aesthetic and quality of life improvement. The efficacy, safety profile, and the simplicity of the injection schedule of PLA make this filling material a potentially attractive treatment.
The tissue response and in vivo molecular stability of injection-molded polyhydroxyacids—polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA, 5–22% VA content)—were studied. Polymers were implanted subcutaneously in mice and extirpated at 1, 3, and 6 month in order to study tissue response and polymer degradation.
All polymers were well tolerated by the tissue. No acute inflammation, abscess formation, or tissue necrosis was observed in tissues adjacent to the implanted materials. Furthermore, no tissue reactivity or cellular mobilization was evident remote from the implant site. Mononuclear macrophages, proliferating fibroblasts, and mature vascularized fibrous capsules were typical of the tissue response. Degradation of the polymers was accompanied by an increase in collagen deposition. For the polylactide series, the inflammatory response after 1 month of implantation was less for materials containing the D-unit in the polymer chain, whereas in the case of the polyhydroxybutyrate/valerates, the number of inflammatory cells increased with increasing content of the valerate unit in the polymer chain. Between 1–3 months, there was slightly more tissue response to the PHB and PHB/VA polymers than to PLA. This response is attributed to the presence of leachable impurities and a low molecular weight soluble component in the polyhydroxybutyrate/valerates. At 6 months, the extent of tissue reaction was similar for both types of polymers.
All polylactides degraded significantly (56–99%) by 6 months. For a poly(L-lactide) series, degradation rate in vivo decreased with increasing initial molecular weight of the injection-molded polymer. Several samples showed pronounced bimodal molecular weight distributions (MWD), which may be due to differences in degradation rate, resulting from variability in distribution of crystalline and amorphous regions within the samples. This may also be the result of two different mechanisms, i.e., nonenzymatic and enzymatic, which are involved in the degradation process, the latter being more extensive at the later stage of partially hydrolyzed polymer. The PHB and PHB/VA polymers degraded less (15–43%) than the polylactides following 6 months of implantation. Generally, the polymer with higher valerate content (19%, 22% degraded most. The decrease in molecular weight was accompanied by a narrowing of the MWD for PHB and copolymers; there was no evidence of a bimodal MWD, possibly indicating that the critical molecular weight that would permit enzyme/polymer interaction had not been reached. Weight loss during implantation ranged from 0–50% for the polylactides, whereas for the PHB polymers weight loss ranged from 0–1.6%.
To evaluate the safety and efficacy of the anabolic steroid, nandrolone decanoate (Deca Durabolin) in patients with HIV wasting who are resistant to nutritional intervention.
A 16-week open trial with subjects who had lost 5-15% of their usual body weight.
HIV/AIDS specialist ambulatory care services, both public and private, in sydney, Australia.
Two hundred and twenty men entered the pre-therapy phase, and of these, 24 failed to gain weight and were enrolled. Seventeen subjects (81%) completed the 16-week trial.
Pre-therapy nutritional assessment and education was conducted by the clinical dietitian. Those who failed to gain weight (10.9%) were treated with nandrolone decanoate (100 mg/ml) by deep intramuscular injection every 2 weeks for 16 weeks.
Changes in weight and body composition (lean body mass, total body water and nitrogen index) were measured by anthropometry, bioelectrical impedance, and in vivo neutron activation. Changes in quality of life were assessed by the 30-item Medical Outcomes Study short form questionnaire. Changes in biochemistry, haematology and immunology were also measured.
There were significant increases in weight (mean, 0.14 kg per week; P < 0.05) and lean body mass (mean, 3 kg by anthropometry; P < 0.005). The change in lean body mass was of similar magnitude across all measurement modalities. Quality of life parameters, especially functionality, increased significantly during the trial. No subject experienced toxicity.
Nandrolone decanoate has beneficial effects on weight, lean body mass and quality of life in selected patients who have mild to moderate HIV wasting.
To evaluate oxandrolone, an oral anabolic steroid with potent anabolic activity and minimal androgenic effects, for the treatment of AIDS-associated myopathy and wasting.
In a multicenter, double-blind study, 63 HIV-seropositive men with > 10% loss of body weight were randomized to receive either placebo, 5 mg/day oxandrolone, or 15 mg/day oxandrolone for 16 weeks. Body weight, neuromuscular evaluation, and measures of well-being were repeatedly assessed.
Patients who received 15 mg/day oxandrolone showed weight gain throughout the 16-week treatment period. Overall, the 5 mg/day oxandrolone group maintained their weight gain over the 16-week period, whereas the placebo group showed continual weight loss. At week 16, significantly more patients in the 15 mg/day dose group reported increases in appetite and activity than those receiving placebo. There were no consistent, dose-related, statistically significant differences from baseline in laboratory values or adverse events.
Oxandrolone, at a dose of either 5 mg/day or 15 mg/day, in contrast to placebo, had a positive impact on the weight and well-being of HIV-seropositive patients suffering from wasting and weakness. Measurable improvement in muscle strength was not noted at the doses employed in this study. Oxandrolone was well tolerated in all the patients who were enrolled in the study. Based on the results reported here, additional studies using higher doses of oxandrolone seem warranted.
Highly active antiretroviral therapy (HAART) for human immunodeficiency virus-1 (HIV-1) and prophylactic therapy for opportunistic infections have increased survival. Adverse effects of HAART include lipid profile alterations, diabetes mellitus, and fat redistribution. These metabolic and physical changes are called the HIV-associated lipodystrophy syndrome. A link to protease inhibitors has been suggested, and more recently to nucleoside reverse transcriptase inhibitors and factors related to duration of HIV-1 infection itself.
Antiretroviral toxicity is an increasingly important issue in the management of HIV-infected patients. With the sustained major declines in opportunistic complications, HIV infection is a more chronic disease, and so more drugs are being used in more patients for longer periods. This review focuses on the pathogenesis, clinical features, and management of the principal toxicities of the 15 licensed antiretroviral drugs, including mitochondrial toxicity, hypersensitivity, and lipodystrophy, as well as more drug-specific adverse effects and special clinical settings.
A careful study of the aging face reveals it to be more than just surface textural wrinkling or loose skin. Changes in three-dimensional topography are responsible for the distinctive phenotypic presentation of the face throughout life. These geometric alterations are secondary to apportioning in the fat compartments and result in the fat dysmorphism characteristic of senescence. Redistributing this fat can rebalance the facial fat compartments and mimic the facial structure present in youth.
A syndrome characterized by loss of fat on the face and limbs, localized fatty deposits on the trunk, and metabolic disturbances is becoming increasingly recognized in the human immunodeficiency virus (HIV) patient population.
To increase awareness of this syndrome among dermatologists and dermatologic surgeons and to review its various treatment options, including liposuction.
We present a patient with HIV lipodystrophy syndrome who underwent tumescent liposuction. We also describe our experience with liposuction in the management of this condition and review the treatment options that have been proposed in the literature.
In the medical management of HIV lipodystrophy, various agents have been utilized but most have yielded disappointing results. Preliminary evidence on the use of tumescent liposuction in these patients suggests that significant improvement in the cosmetic disfigurement can be achieved.
This syndrome is common among HIV-infected patients and remains difficult to treat. Although medical therapy may be preferable in most patients, liposuction represents a viable option in selected individuals.
Localized facial lipodystrophy is a socially disabling complication affecting many HIV-seropositive patients receiving triple combination therapy. The exact pathogenesis is not well understood and proper therapy is not available. The purpose of this pilot-study was to determine whether a hyaluronic acid get, used to treat wrinkles for cosmetic reasons, would be a safe and effective treatment for facial lipodystrophy in patients receiving triple combination therapy. Seven patients were treated with intradermal gel injections after skin tests. There were no immediate or late allergenic reactions or other side effects. Within the limitations of the product, overall satisfaction regarding the results was high.
The dramatic clinical benefit of highly active antiretroviral therapy has been offset, to an extent, by the development of unforeseen long-term toxicities. Of these, the HIV lipodystrophy syndrome is most prominent. The array of related but possibly separate manifestations includes fat deposition and atrophy and metabolic complications such as hyperlipidemias and diabetes mellitus. These have been attributed to the use of protease inhibitors, but other factors may be involved, particularly the use of nucleoside reverse transcriptase inhibitors, especially stavudine. The pathogenesis of any of the manifestations of the syndrome remains to be explained. The metabolic complications may respond to standard treatments, but most therapies directed at fat changes have been unsuccessful. This review will summarize the state of knowledge in the field.
The HIV associated lipodystrophy syndrome is characterized by fat loss from the periphery, fat accumulation in the abdominal, dorsocervical regions and breasts, and hyperlipidaemia, insulin resistance and lactic acidaemia. Although several mechanisms have been proposed to explain these abnormalities, the exact aetiology of the condition remains unclear and will likely prove to be complex. The principal clinical concerns that arise from this disorder are possible increased risks of premature atherosclerosis and cardiovascular disease. A variety of therapeutic interventions, designed to limit these risks, are under evaluation.
HIV-related lipodystrophy has emerged as one of the most prevalent problems for patients with HIV, since this infection can now be seen as a chronic disease. Despite its growing importance, crucial issues such as aetiopathogenesis, diagnosis, prevention and therapy remain largely unknown and unexplored. Current evidence suggests that aetiology is multifactorial. HIV infection, antiretroviral therapy and patient-related factors probably all contribute to the development of lipodystrophy. The lack of a formal definition and the nature of wasting syndromes that affect HIV-infected patients can hinder the diagnosis and treatment of lipodystrophy. Body fat changes have a major negative impact on the quality of life of patients. Metabolic abnormalities are also well known cardiovascular risk factors that can increase the morbidity and mortality due to cardiovascular disorders in a relatively young population. As yet, we do not know whether lipodystrophy is preventable or reversible. Several therapeutic approaches have been tested with limited success, however potential complications must be considered. These therapeutic approaches include general health measures (diet, exercise and discontinuation of smoking), switching antiretrovirals (from protease inhibitors to non-nucleoside reverse transcriptase inhibitors or abacavir, or from stavudine to other nucleoside reverse transcriptase inhibitors) and use of drugs with metabolic effects (metformin, thiazolidinediones, recombinant growth hormone and anabolic steroids). A judicious use of available data, and opting for an individualised approach seems the best option for management of this problem at present.
The primary reason patients seek aesthetic treatments is to combat the signs of aging. However, the majority of facial treatments and procedures fill specific wrinkles or pull-taught sagging skin, without returning the volume and contours of a youthful face. Injectable poly-L-lactic acid (Sculptra) is a synthetic, biodegradable polymer, popular in Europe for the correction of lipoatrophy. The novel technique and mechanism of action of this product require physicians to adjust their practice of treating a specific line to returning volume to a facial area. Sculptra has been used successfully for the correction of nasolabial folds, mid and lower facial volume loss, jaw line laxity, and other signs of facial aging. Sculptra treatment provides a minimally invasive, effective, and prolonged (18-24 months) facial enhancement correction with a low frequency of side effects and no need for allergy testing.
Polylactic acid (PLA, New-Fill; Medifill, London, UK and Dermic Labs, a division of Eventis, Strasbourg, France) injections into the deep dermis increase fibroblast numbers and collagen production. The substance is widely used in medical applications including cosmetic procedures.
HIV-positive individuals with facial lipoatrophy (based on physician assessment) were randomized to immediate (weeks 0, 2 and 4) or delayed (weeks 12, 14 and 16) PLA given as three bilateral injections 2 weeks apart into the deep dermis overlying the buccal fat pad. Assessments included facial ultrasound, visual analogue scales, the Hospital Anxiety and Depression Scale (HADS) and assessment using photographs at weeks 0, 12 and 24.
All 30 patients completed 24 weeks of treatment. The median age of the patients was 41 years, with a mean of 80 months of nucleoside reverse transcriptase inhibitor (NRTI) therapy and a mean of 44 months of prior protease inhibitor (PI) therapy. The median CD4 count was 428-460 cells/microL, with 47% of patients in the immediate-treatment group and 93% of patients in the delayed-treatment groups with <50 HIV-1 RNA copies/mL at baseline. No differences in immunological, virological, biochemical, haematological or metabolic parameters emerged during the study. Injections were well tolerated with only two adverse events (cellulitis and bruising) recorded, one of which delayed treatment by 1 week. There were no discontinuations. Patient visual analogue assessments, photographic assessments, and anxiety and depression scores improved with treatment. At week 12, immediate-treatment patients had significantly better visual analogue scores (7 vs. 1, P<0.001) and lower anxiety scores (6 vs. 9, P=0.056) than delayed-treatment patients. Benefits on visual analogue and HADS scores persisted until week 24.
PLA injections led to improvements in patient self-perception, anxiety and depression scores in individuals with facial lipoatrophy. Adverse events were uncommon. The benefits of PLA persisted for at least 18 weeks beyond the last injection.
US Food and Drug Admisins-tration. FDA approval of Sculptra for treating HIV facial lipoatrophy Available at: www.fda
- R Klein
- Struble
Klein R, Struble K. US Food and Drug Admisins-tration. FDA approval of Sculptra for treating HIV facial lipoatrophy. Available at: www.fda. gov//bbs/topics/news/2004/NEW0100.html. Ac-cessed 5/6/06.
HIV lipo-dystrophy syndrome
- Qaqish Rb
- Rublein E J Fisher
Qaqish RB, Fisher E, Rublein J, et al. HIV lipo-dystrophy syndrome. Pharmacotherapy 2000; 20:13–22.
Long term follow-up of patients with HIV receiving rhGH: another dilemma of early versus delayed inter-vention? Presented at the 13th International AIDS Conference
- Torres R J Dadman
Torres R, Dadman J, Kassous J, et al. Long term follow-up of patients with HIV receiving rhGH: another dilemma of early versus delayed inter-vention? Presented at the 13th International AIDS Conference. Durban, South Africa, July, 2000. Abstract WePeB4234.
US Food and Drug Admisinstration. FDA approval of Sculptra for treating HIV facial lipoatrophy
- R Klein
- K Struble
Long term follow-up of patients with HIV receiving rhGH: another dilemma of early versus delayed intervention? Presented at the 13th International AIDS Conference
- R Torres
- J Dadman
- J Kassous
Adverse effects of antiretroviral therapy
- Carr